Minimally Invasive Implant and Method

ABSTRACT

Apparatus and methods are provided for treating urinary incontinence, fecal incontinence, and other pelvic defects or dysfunctions, in both males and females, using one or more lateral implants to reinforce the supportive tissue of the urethra. The implants can be configured as a sling device having at least one extension arm and a tissue support portion having an eyelet, wherein a portion of the at least one extension arm is adapted to slide through and adjustably attach with the eyelet.

RELATED APPLICATION

This application is a Continuation of U.S. application Ser. No.13/335,472, filed Dec. 22, 2011, which is a Continuation-In-Part of U.S.application Ser. No. 13/060,467, filed May 4, 2011, and now issued asU.S. Pat. No. 8,968,181, which claims priority to and the benefit ofInternational PCT Patent Application No. PCT/US2009/054909, filed Aug.25, 2009, which claims priority to and the benefit of U.S. ProvisionalApplication No. 61/091,586, filed Aug. 25, 2008; and also claimspriority to and the benefit of U.S. Provisional Application No.61/426,117, filed Dec. 22, 2010; with each of the above-referencedapplications being fully incorporated herein by reference in theirentirety.

FIELD OF THE INVENTION

The present invention relates to apparatus, tools and methods fortreating pelvic conditions by providing and using one or more pelvicimplants to support pelvic tissue.

BACKGROUND OF THE INVENTION

It has been reported that over 13 million American men and women of allages suffer from urinary and fecal incontinence. The social implicationsfor an incontinent patient include loss of self-esteem, embarrassment,restriction of social and sexual activities, isolation, depression and,in some instances, dependence on caregivers. Incontinence is the mostcommon reason for institutionalization of the elderly.

The urinary system consists of the kidneys, ureters, bladder andurethra. The bladder is a hollow, muscular, balloon-shaped sac thatserves as a storage container for urine. The bladder is located behindthe pubic bone and is protected by the pelvis. Ligaments hold thebladder in place and connect it to the pelvis and other tissue. FIG. 1schematically illustrates the relevant female anatomy. The urethra 16 isthe tube that passes urine from the bladder 14 out of the body. Thenarrow, internal opening of the urethra 16 within the bladder 14 is thebladder neck 18. In this region, the bladder's bundled muscular fiberstransition into a sphincteric striated muscle called the internalsphincter. FIG. 2 schematically illustrates the relevant male anatomy.The urethra 16 extends from the bladder neck 18 to the end of the penis22. The male urethra 16 is composed of three portions: the prostatic,bulbar and pendulus portions. The prostatic portion is the widest partof the tube, which passes through the prostate gland 24. FIG. 3 is aschematic view of the anatomy of the anus and rectum. The rectum 1 isthe most distal portion of the gastrointestinal tract. The exterioropening of the rectum is the anus 2. Fecal continence is related tocontrol of the exterior sphincter 3 and interior sphincter 4 of theanus.

Urinary incontinence may occur when the muscles of the urinary systemare injured, malfunction or are weakened. Other factors, such as traumato the urethral area, neurological injury, hormonal imbalance ormedication side-effects, may also cause or contribute to incontinence.There are five basic types of incontinence: stress incontinence, urgeincontinence, mixed incontinence, overflow incontinence, and functionalincontinence. Stress urinary incontinence (SUI) is the involuntary lossof urine that occurs due to sudden increases in intra-abdominal pressureresulting from activities such as coughing, sneezing, lifting,straining, exercise and, in severe cases, even simply changing bodyposition. Urge incontinence, also termed “hyperactive bladder”“frequency/urgency syndrome” or “irritable bladder,” occurs when anindividual experiences the immediate need to urinate and loses bladdercontrol before reaching the toilet. Mixed incontinence is the mostcommon form of urinary incontinence. Inappropriate bladder contractionsand weakened sphincter muscles usually cause this type of incontinence.Mixed incontinence is a combination of the symptoms for both stress andurge incontinence. Overflow incontinence is a constant dripping orleakage of urine caused by an overfilled bladder. Functionalincontinence results when a person has difficulty moving from one placeto another. It is generally caused by factors outside the lower urinarytract, such as deficits in physical function and/or cognitive function.

SUI is generally thought to be related to hypermobility of the bladderneck or an intrinsic urethral sphincter defect. A variety of treatmentoptions are currently available to treat incontinence. Some of thesetreatment options include external devices, behavioral therapy (such asbiofeedback, electrical stimulation, or Kegal exercises), injectablematerials, prosthetic devices and/or surgery. Depending on age, medicalcondition, and personal preference, surgical procedures can be used tocompletely restore continence.

Conservative management of SUI can include lifestyle changes, such asweight loss, smoking cessation, and modification of intake of diureticfluids such as coffee and alcohol. With regard to surgical treatments,the purported “gold standard” is the Burch Colposuspension, in which thebladder neck is suspended. Mid-urethral slings have been similarlyeffective. One type of procedure, found to be an especially successfultreatment option for SUI in both men and women, is a sling and supportprocedure.

A sling procedure is a surgical method involving the placement of asling to stabilize or support the bladder neck or urethra. There are avariety of different sling procedures. Slings used for pubovaginalprocedures differ in the type of material and anchoring methods. In somecases, the sling is placed under the bladder neck and secured viasuspension structures or sutures to a point of attachment (e.g., tissueor bone) through an abdominal and/or vaginal incision.

Although serious complications associated with sling procedures areinfrequent, they can occur. Complications for certain sling proceduresmay include urethral obstruction, development of de novo urgeincontinence, hemorrhage, prolonged urinary retention, infection, damageto surrounding tissue and erosion.

Fecal incontinence, like urinary incontinence, has proven to bechallenging to treat. Patients whose fecal incontinence is caused byexternal anal sphincter injury is treated surgically, as with asphincteroplasty. Other patients, though, are considered to haveneurogenic or idiopathic fecal incontinence, and efforts to treat thesepatients has been less successful. Various procedures, such as postanalrepair, total pelvic floor repair, muscle transposition techniques,dynamic graciloplasty, artificial sphincter procedures, and sacral nervestimulation. Success has been limited, and the various treatmentmodalities can result in morbidity.

There is a desire for a minimally invasive yet highly effectivetreatment modality that can be used with minimal to no side effects forthe treatment of both urinary and fecal incontinence. Further, themethod of treatment should also improve the quality of life forpatients.

SUMMARY OF THE INVENTION

The present invention can include surgical instruments, implantablearticles, and methods for urological applications, particularly for thetreatment of stress and/or urge urinary incontinence, fecalincontinence, and prolapse and perineal floor repairs. As noted, theusual treatments for SUI include placing a sling to either compress theurethral sphincter or to elevate or support the neck of the bladderdefects.

Embodiments of the present invention can include apparatus and methodsfor treating urinary incontinence, fecal incontinence, and other pelvicdefects or dysfunctions, in both males and females using one or morelateral implants to reinforce the supportive tissue of the urethra. Theimplants are configured to engage and pull (e.g., pull up) lateralurethral support (e.g., endopelvic fascia) tissue to cause thesub-urethral tissue to tighten and provide slack reduction for improvedsupport. As such, the implants of such embodiments can be utilized toeliminate the need for mesh or other supportive structures under theurethra that is common with other incontinence slings. The implants canbe shaped to facilitate such support, e.g., provided with anchoring endportions or configurable in “U,” “V” or like shapes. Further, one ormore anchors or tissue engagement portions can be employed to attach andstabilize the implants to the tissue. Other embodiments of the presentinvention can include a supportive sling implant having one or more armportions and a tensioning rod. Such embodiments can be provided in atraditional supportive configuration under the urethra, or laterallypositioning with respect to the urethra, as described herein. In varioussuch embodiments, the sling can include a tissue support portion havinga first eyelet and a second eyelet, a first extension arm, and a secondextension arm. The first extension arm can include an anchor portion andan opposing end adjustment element, with at least a length of the firstextension arm adapted to slide through the first eyelet of the tissuesupport portion. Similarly, the second extension arm can include ananchor portion and an opposing end adjustment element, with at least alength of the first extension arm adapted to slide through the secondeyelet of the tissue support portion.

The support portion can be included with one of the extension arms toprovide a two-piece construct. For instance, the first extension arm andits corresponding support portion can include the eyelet and ananchoring portion. The second arm extension can slidably engage with theeyelet to define the elongate sling. Alternatively, the support portioncan be a separate element of a three-piece construct. As such, thesupport portion for such embodiments can include two or more eyelets.Two separate extension arms can be included with such embodiments (e.g.,each with anchors and adjustment elements), with each extension armadapted to slidably engage with a respective eyelet of the separatesupport portion.

Certain embodiments of the implant or sling can include one or moreindicia to assist in deployment, adjustment and tensioning of theimplant or sling.

Embodiments of the present invention can provide smaller implants, fewerimplant components, thus reducing the size and number of incisions,improving implant manipulation and adjustment, and the complexity of theinsertion and deployment steps.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a schematic view of the female urinary system.

FIG. 2 shows a schematic view of the male urinary system.

FIG. 3 shows a schematic view of the anatomy of the anus and rectum.

FIG. 4 shows a pelvic implant device in accordance with embodiments ofthe present invention.

FIG. 5 shows an introducer or insertion device capable of use withembodiments of the present invention.

FIG. 6 shows a generally U-shaped pelvic implant device in accordancewith embodiments of the present invention.

FIG. 7 shows an anchor of a pelvic implant device in accordance withembodiments of the present invention.

FIG. 8 shows a side view of the pelvic implant device anchor of FIG. 7.

FIG. 9 shows a pelvic implant device having anchoring members along aportion of the extension portion in accordance with embodiments of thepresent invention.

FIG. 10 shows an anchoring pelvic implant device in accordance withembodiments of the present invention.

FIG. 11 shows a pelvic implant device having a multi-barbed anchor inaccordance with embodiments of the present invention.

FIGS. 12-15 show various pelvic implant devices with a leading anchorand a trailing base or bulk anchor in accordance with embodiments of thepresent invention.

FIG. 16 shows the implantation of pelvic implant devices in the lateralurethral support tissue in accordance with embodiments of the presentinvention.

FIG. 17 schematically shows the implantation of U-shaped pelvic implantdevices in the lateral urethral support tissue in accordance withembodiments of the present invention.

FIG. 18 schematically shows the implantation of U-shaped pelvic implantdevices in the lateral urethral support tissue in accordance withembodiments of the present invention.

FIG. 19 schematically shows the implantation of implant devices, havingleading anchor and trailing bulk anchors, to provide tensioning supportfor the lateral urethral support tissue in accordance with embodimentsof the present invention.

FIGS. 20-21 schematically show the implantation of implant devices,having leading anchor and trailing bulk anchors, to provide tensioningsupport for the lateral urethral support tissue in accordance withembodiments of the present invention.

FIGS. 22-23 schematically show the implantation of implant devicesthrough the obturator and into the lateral urethral support tissue inaccordance with embodiments of the present invention.

FIGS. 24-25 schematically show the retropubic implantation of implantdevices to provide tensioning support for the lateral urethral supporttissue in accordance with embodiments of the present invention.

FIG. 26 shows an implant device having a toggle bolt anchor selectivelyengaged with an introducer device in accordance with embodiments of thepresent invention.

FIG. 27 shows implant devices having a toggle bolt anchor and a tubularbase anchor in accordance with embodiments of the present invention.

FIG. 28 schematically shows the implantation of the implant devices ofFIG. 27 to provide support of the lateral urethral support tissue inaccordance with embodiments of the present invention.

FIG. 29 shows an implant device having a toggle bolt anchor, a tubularbase anchor, and an intermediate urethral cradling portion in accordancewith embodiments of the present invention.

FIG. 30 shows a tubular implant device of device portion in accordancewith embodiments of the present invention.

FIG. 31 shows an implant device having a tubular portion and a generallyflat portion in accordance with embodiments of the present invention.

FIG. 32 schematically shows implantation of a tubular and/or flatimplant device to provide tensioning support for the lateral urethralsupport tissue in accordance with embodiments of the present invention.

FIG. 33 shows an implant device having a first arm and a second arm inaccordance with embodiments of the present invention.

FIG. 34 schematically shows implantation of the implant device of FIG.33 along a retropubic pathway in accordance with embodiments of thepresent invention.

FIG. 35 schematically shows implantation of the implant device of FIG.33 along a transobturator pathway in accordance with embodiments of thepresent invention.

FIG. 36 shows an implant device having a first arm portions and secondarm in accordance with embodiments of the present invention.

FIG. 37 schematically shows implantation of the implant device of FIG.36 along a retropubic pathway in accordance with embodiments of thepresent invention.

FIG. 38 schematically shows implantation of the implant device of FIG.36 along a transobturator pathway in accordance with embodiments of thepresent invention.

FIG. 39 shows an implant device having arm portions and adjustmentindicia in accordance with embodiments of the present invention.

FIGS. 40-41 show slidable adjustment of the implant device of FIG. 39 inaccordance with embodiments of the present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring generally to FIGS. 1-41, like reference numerals can designateidentical, similar or corresponding parts throughout the views. Thefollowing description is meant to be illustrative only, and not limitingother embodiments of this invention that will be apparent to those ofordinary skill in the art in view of this description.

One aspect of the present invention is an apparatus and method oftreating urinary incontinence in males or females. In variousembodiments, one or more implants or implant members are placed instrategically located positions to pull up or otherwise tighten tissueand/or muscle lateral to the urethra to generally re-establish theoriginal anatomical structure of the patient. Various systems, devices,structures, techniques and methods, alone or in combination, asdisclosed in U.S. Pat. Nos. 6,911,003, 6,612,977, 6,802,807,2002/0161382, 2004/0039453 and 2008/0045782, and International PCTPublication No. 2008/057261, can be employed with the present invention,with the above-identified disclosures being incorporated herein byreference in their entirety. The devices or structures described hereincan be employed or introduced into the pelvic region of the patienttransvaginally, percutaneously or in any other manner known by those ofordinary skill in the art.

Various embodiments of the present invention can include a tensioning orsupport implant device 30 having an extension portion 32 and one or moreengagement portions 34, as shown in FIG. 4. The one or more engagementportions can include a first anchor 34 a at a first or leading end ofthe tensioning device 30, with a second anchor 34 b provided at anopposite trailing end of the device 30. The extension portion 32 can beconstructed of a compatible mesh or like porous material known for useand compatibility with urethral slings, other pelvic support devices,and the like. The mesh material can facilitate the infiltration oftissue and cells within the extension portion 32 to promote tissuein-growth and, in turn, fixation of the device 30 to the surroundinganatomical structure. The extension portion 32 can also includeprotrusions, serrated edges, extending fibers, or similar structuralfeatures to promote tissue fixation and in-growth. In other embodiments,the extension portion 32 can be constructed of a flexible, orsemi-rigid, length of a compatible generally non-porous material. Thelength and flexibility of the device 30 and corresponding extensionportion 32 can vary greatly depending on the particular procedure andanatomical support application. The extension portion 32 can begenerally planar at introduction, pre-shaped or pre-formed, or otherwiseconfigured to allow for adaptation, manipulation and shaping during theimplantation procedure. Various embodiments of the extension portion 32can be capable of forming into a generally V-shaped or U-shaped device(FIG. 6), or otherwise adapted for flexible or selective manipulationand traversal through, around and/or along various tissue and muscles ofthe pelvic region. In certain embodiments, the length of the device 30can range from 0.5 to 6 cm. It is also possible to have lengths greaterthan or less than 0.5 to 6 cm.

In certain embodiments, the implant can be constructed in the form of acollapsible synthetic mesh patch, and can include an adhesive covering(e.g., fibron glue). Further, an umbrella-like feature can be includedwith wire splines or members extending from the patch. The umbrella-likefeature can be connected with the patch via a connection structure, suchas a ring, fastener, etc. A portion of the implant introducer (e.g.,plunger and/or wire) can be configured to advance the patch and deployand/or expand the umbrella-like feature to provide tissue engagement forthe patch.

The one or more engagement portions 34 can be configured as fixating, orself-fixating, tips or anchors 34 adapted for penetration and fixationwithin target tissue or muscle (T) of the pelvic region. As shown inFIGS. 4, 6 and 7-11, the anchors 34 can vary in shape, size andplacement along the device 30. For instance, as shown in FIGS. 4 and 6,the anchors 34 can be integrated, attached or otherwise providedproximate the ends of the extension portion 32. The extension portion 32can be connected to the anchors 34 via an end portion 36 of the anchors34. A myriad of attachment structures or techniques can be utilized toconnect the ends of the extension portion 32 to the end portion 36 ofthe anchors 34. Further, the anchors 34 can include opposing tines orbarbs 38 to facilitate penetration and fixation within the targettissue. Other embodiments, such as those depicted in FIGS. 9-11, caninclude one or more tines 38 provided along portions of the extensionportion 32 (FIG. 9), or a plurality of barbs 38 disposed along theanchors 34 (FIG. 11). Moreover, the one or more engagement portions 34can be configured as toggle bolt anchors (FIG. 26), tubular members,planar members, bulbous members and the like, any of which can beconstructed of compatible polymers, metals, mesh or non-porousmaterials, or bio-absorbable or non-absorbable materials. As depictedand described herein, the engagement portions 34 can be adapted toengage various target tissue regions, including the endopelvic fascia,the rectus fascia/muscle, the obturator muscle, and other anatomicalstructures of the pelvis.

In addition, a sheath or sleeve 40 can be selectively provided along alength of the extension portion 32 to facilitate introduction andinsertion of the device 30 within the pelvic region of the patient, asdepicted in FIG. 10. One or more insertion or introduction devices 42can be employed to facilitate traversal of the device 30 within thepelvic region, and to facilitate deployment of the device 30 (e.g.,anchors 34) into the target tissue location. Various known insertiondevices 42 can be utilized, including those disclosed in thepreviously-incorporated patent references. A needle embodiment of thedevice 42 can include a handle, a tubular member 43 (straight orcurved), and a tip 45 adapted for selective engagement with one or morecomponents of the implants disclosed herein. As depicted in FIG. 10, theextension portion 32 can include a plurality of fibrous material orstrands 44 adapted to further promote tissue in-growth and fixation.

As detailed herein, various embodiments of the present invention areconfigured to treat urinary incontinence by providing support to thetissue or anatomical structure proximate or surrounding the urethra,rather than providing more conventional hammock-like support under theurethra. The device 30 and engagement aspects of the invention for suchembodiments can vary greatly, as detailed herein.

As shown in FIGS. 12-15, the device 30 can include the barbed anchor 34at a leading end of the extension portion 32 and a bulk base member 50at the opposite trailing end. The extension portion 32 can beconstructed of a mesh material (FIG. 12), or another porous ornon-porous material (FIGS. 14-15). Further, the base member 50 can bemesh, or another porous or non-porous material, and can take on anyvariety of shapes, including planar, bulbous, tubular, etc. The basemember 50 can be integrated with the extension portion 32, attachedusing fasteners 52 (e.g., rivet), bonded, or otherwise attachedutilizing known structures and techniques. In other embodiments, theextension portion 32 can be made of random fibers, or a weaved, braided,twisted, or knitted polymer material.

As depicted in FIG. 16, the device 30 can be inserted along a pathgenerally toward the obturator foramen for penetration through theendopelvic fascia (EF) on either or both sides of the urethra 16. Assuch, the anchors 34 are positioned for fixation with tissue or muscleproximate the fascia so that the base member 50 is disposed on the entryside of the fascia. The base member 50 of each device 30 can be sizedand shaped such that it remains on the entry side of the fascia and caninclude one or more anchors, protrusions or similar structures toprovide additional engagement and retention against the fascia. Theanchors 34 are advanced and positioned to penetrate through or otherwiseengage with selective target tissue such that the laterally extendingsub-urethral tissue, such as the endopelvic fascia, is pulled upward toremove slack and relocate the fascia and/or urethra to a more optimaland correct anatomical position. Other adjustment mechanisms andtechniques can also be used to raise the fascia to provide the desiredtightening or slack reduction in the laterally extending urethralsupport tissue. The devices 30 of FIGS. 14-15 function in the samemanner, except that the extension portion 32 and base members 50 canassume different design configurations and can be constructed ofdifferent materials, such as relatively stiff or flexible polymers,mesh, non-porous mesh and other known compatible materials.

Structures or portions of the various embodiments detailed herein can beconstructed of materials such as polypropylene, polyglycolide,poly-l-lactides, or other known biodegradable (re-absorbable) ornon-biodegradable polymers. Further, growth factors or stem cells can beseeded or otherwise provided with one or more of the components of thedevice 30 to facilitate healing or tissue in-growth. In addition tointroduction and deployment of the device 30 with a needle introducerdevice, a cannula or catheter system can be utilized as well.

The embodiment of FIGS. 16-17 includes an implant device 30 having theextension portion 32 and one or more engagement or anchor portions 34provided at an end region of the extension portion 32. The device 30 canbe designed with a level of flexibility allowing a user to easily directand advance the device 30 and to allow for manipulation of the device 30into a generally U-shaped or similar configuration during deployment andanchoring. In one embodiment, the device 30 is adapted to generallyaugment the lateral tissue of the supportive pelvic floor of thepatient. For instance, a first of the anchors 34 a can be insertedthrough the endopelvic fascia for fixation within tissue. As such, theother anchor 34 b can be adjusted or pulled to tighten and raise thesupportive urethral tissue. One or more of the anchors 34 a, 34 b can befixated to tissue near or at the obturator internus muscle or obturatormembrane. Upon pulling the support tissue up to generally obtain thecorrect anatomical urethral support, the second anchor is fixated withinthe proximate tissue, with the bend of the extension portion 32extending through the fascia. This process can be repeated for thesupportive tissue on the other side of the urethra to provide bilateralaugmentation and support.

FIG. 18 shows an embodiment of the device 30 having a first anchor 34 aand a second anchor 34 b, with the portion 32 extending therebetween.The anchors 34 a, 34 b can be configured in accordance with the variousdesigns disclosed herein. For example, the first anchor 34 a can be apenetrating tip, with the second anchor 34 a be shaped as a tubular orbulk anchor. One of the anchors can be fixated in tissue above thefascia and the other of the anchors secured at, near or through thefascia to pull the supportive urethral tissue up to eliminate slack inthe tissue. This process can be repeated on the other side of theurethra to provide bilateral augmentation and support. Embodiments ofthe extension portion 32 can be constructed of mesh, or braded, twisted,knitted, tubular, or collagen matrix materials to facilitate fixationand tissue in-growth. Further, a plurality of such devices 30 can beimplanted on either or both sides of the urethra to promote tissueaugmentation and support.

FIGS. 20-21 show certain embodiments of the present invention anddevices 30 similar to that depicted in FIG. 16. The bulk anchor 34 b(e.g., tubular, toggle (FIG. 26), flat, etc.) can be inserted throughthe supportive tissue, such as the endopelvic fascia, or it can resideunder the supportive tissue, with the anchor 34 a extending up throughthe tissue. As such, either of the anchors 34 a, 34 b can be positionedon the opposite side of the supportive tissue. Further, at least one ofthe anchors can serve to penetrate the supportive tissue at one or morelocations along the tissue. For instance, certain embodiments of thedevice 30 can be utilized to weave or thread in and out of, and along,the tissue to provide a supportive undulating layout for the extensionportion 32. This can facilitate attachment, better distribute pullingforce on or along the tissue, and provide like support benefits.

As shown in FIGS. 22-23, an outside-in implant approach can be employedfor the device 30. Namely, a skin incision just inferior to where theadductor longus inserts into the pubic ramus can be created. Then, afirst anchor 34 a of the device 30 can be passed around the ischiopubicramus and inserted through the obturator foramen and internus muscle andinto the tissue lateral to the urethra, e.g., endopelvic fascia thatsupports the bladder neck and urethra. Once fixated, the device 30 canbe pulled to provide tension along the extension portion 32 to augmentand return the urethral support tissue to a correct anatomical position.At that point, the proximal opposing end of the device 30 and extensionportion 32 can be anchored or otherwise positioned to maintain thetension on the device 30. Any of the needle and/or cannula introducerdevices described herein can be employed to insert and deploy the device30 within the patient. Such an embodiment of the device 30 can provideeasier access and patient positioning, can eliminate the need fordissection under the urethra, and can be implanted while the patient isawake such that the device 30 can be selectively adjusted based onindications and movement of the patient. Embodiments of the base or endof the extension portion 32 on the entry side of the tissue could alsobe glued, sutured or otherwise fixated in or at the tissue using variousknown structures and techniques. Again, the device 30 can be implantedon either side of the urethra to provide bilateral support. FIG. 23discloses a variation on this embodiment, with the extension portion 32being constructed of a non-porous material, such as a suture, polymermaterial, string, etc.

FIGS. 24-25 depict another embodiment of the implant device 30,introduced along a retropubic path, rather than a transobturator path.One or more skin incisions are generally created such that the device 30can extend down on either, or both sides of the urethra, with at leastone anchor 34 extending into the endopelvic fascia to the anteriorvaginal wall. Like the other embodiments disclosed herein, fixation ofthe implant device 30 to the lateral supporting tissue of the urethrapermits adjustment to return the supportive tissue to its correctanatomical position. Again, any of the anchors 34, extension portions 32and introducer devices described herein can be employed with theembodiment of FIGS. 24-25.

FIGS. 27-29 show various embodiments of the implant device 30 includingengagement or anchoring portions 34 a, 34 b at each end of the extensionportion 32 to provide lateral support of the urethra. The anchors caninclude any of the structures or features described herein. For example,one embodiment includes a toggle anchor 34 a and a tubular (e.g., mesh)base anchor 34 b. The tubular base 34 b can include cap or otherstructure 35 provided at its ends Like other embodiments of device 30,at least one of the anchors, such as tubular base 34 b, can be engagedwith lateral support tissue of the urethra such that the tissue can betensioned or raised to remove slack. An adjustment member 60, e.g., rod,suture or like feature, can be included to provide selective adjustmentof the device 30 to further facilitate tension control. For thoseembodiments including tubular engagement features 34 b, the features 34b can be of a mesh construction to promote tissue fixation andin-growth. As shown in FIG. 29, this embodiment of the device 30 canfurther include an intermediate support 62 adapted for positioning underthe urethra to provide additional support. The support 62 can be porousor non-porous, and any of the structures (e.g., anchors 34, support 62)can be constructed of re-absorbable or non-absorbable materials.

FIGS. 30-32 depict implants 70 capable of fixation along a portion ofthe lateral urethral support tissue, e.g., the endopelvic fascia. Theseimplants 70 can include one or more tubular and/or flat mesh structures72 adapted for engagement with the support tissue to provide adjustmentwith and/or tension on the tissue. The structures 70, 72 can also beadapted for selective engagement with an introducer device 42 tofacilitate insertion and deployment. The implants can be providedwithout anchors 34, wherein the construct and features (e.g.,protrusions, mesh, abrasions, adhesives, fibers, etc.) of the implantcan provide the attachment structures necessary to engage with andprovide adjustable tension on the support tissue. Other embodiments caninclude anchors 34 to penetrate or engage the lateral tissue. Further,the implants 70 can be constructed of re-absorbable or non-absorbablematerials.

The embodiments of FIGS. 33-38 can include an implant device 80 having afirst extension arm 82, a second extension arm 84, and an adjustmentmember 86 provided with one or both of the extension arms 82, 84. Theextension arms 82, 84 can include one or more anchors 88 at theirrespective ends. The arms 82, 84 can be constructed of a porous mesh, orother materials as described herein for the extension portion 32 ofdevices 30. Similarly, the anchors 88 can assume the configuration ofany of the anchors 34 described herein. Components of the device 80,including the arms and adjustment member, can be constructed ofcompatible materials such as polypropylene, PGA, PLLA, mesh, braids,ropes, filaments, and the like.

Each of the arms 82, 84 (e.g., distinct or separate members) can bepassed through one or more vaginal incisions, along a retropubicpathway, until the anchor 88 is secured in tissue, such as the rectusfascia/muscle, as shown in FIGS. 34 and 37. Further, a portion of eitherarm can extend under the urethra to provide cradling support (e.g., 82or 82 b). To tension the device 80, the member 86 (e.g., rod or polymerextension) of one or both of the arms 82, 84 can be inserted or engagedwith an attachment or locking mechanism 90 (e.g., fastener, device,aperture, etc.) of the other arm or implant portion. The member 86 canthen be slid along or through the locking mechanism 90 to engage thecomponents until an appropriate tension is obtained. The remainingportion of the member 86 extending below the arms can be cut off anddiscarded. In other embodiments, each arm 82, 84 could include themember 86, or like adjustment mechanisms, to facilitate balanced orequal tensioning on either side of the urethra. For example, as shown inFIGS. 36-38, the first extension arm 82 includes separate portions 82 aand 82 b, with the portion 82 a adapted for attachment to or through oneof the apertures or locking mechanisms 90 a of portion 82 b, and theother of the apertures or locking mechanisms 90 b of portion 82 badapted for receiving the second extension arm 84. As shown in FIGS. 35and 38, the device 80 can be deployed, and the procedure performed alonga transobturator pathway as well, with the anchors 88 being secured inthe obturator muscle or like tissue on either side of the pelvis.

For those embodiments having an eyelet or aperture 90 to interconnectthe arms 82, 84 or arm portions (e.g., 82 a, 82 b and 84), various tools(e.g., insertion and push tools), devices, mechanisms (e.g., grommets,and locking or adjustment elements), and techniques can be used tofacilitate selective attachment and tensioning of the arms, includingthose disclosed in U.S. Patent Application Publication No. 2010/0261955,which is hereby incorporated by reference herein in its entirety.Embodiments of the present invention provide key advantages overfixed-length slings, thereby allowing treatment of a large range ofpatients with a wide range of anatomical dimensions with a singleadjustable device.

Various sling devices 30, including those having one or more extensionarms 82, 84 (e.g., FIGS. 33-38), can include one or more indicia 100 toindicate adjustment, length and positioning thresholds and targets forthe physician—e.g., large (100 a), medium (100 b), small (100 c), etc.,as shown in FIGS. 39-41. These indicia 100 can be included along anyportion of the sling 30, including the portion intended for generalcentral alignment with the anatomical structure to be supported. Theindicia 100 can provide broad or granular adjustment indicators, forgeneral alignment, or alignment with anatomical structures such as theurethra, bladder neck, or like structures. The number of indicia 100,and the visual representations, design and look, can vary greatlydepending on the particular sling 30 use application. The indicia 100can be provided to the corresponding portion of the sling 30 withcompatible ink, polymer coating, coloring, molding, bonding, or byadding or otherwise including elements that are adapted to stand out(e.g., color, shape, size, design, etc.) along the designated slingportion.

A variety of materials may be used to form portions or components of theimplants and devices 30, including Nitinol, polymers, elastomers, porousmesh, thermoplastic elastomers, metals, ceramics, springs, wires,plastic tubing, and the like. The systems, components and methods mayhave a number of suitable configurations known to one of ordinary skillin the art after reviewing the disclosure provided herein.

All patents, patent applications, and publications cited herein arehereby incorporated by reference in their entirety as if individuallyincorporated, and include those references incorporated within theidentified patents, patent applications and publications.

Obviously, numerous modifications and variations of the presentinvention are possible in light of the teachings herein. It is thereforeto be understood that within the scope of the appended claims, theinvention may be practiced other than as specifically described herein.

What we claim is:
 1. An elongate implantable incontinence sling system,comprising: a tissue support portion having a first eyelet and a secondeyelet; a first extension arm having a first anchor portion and a firstextension member, with at least a length of the first extension armadapted to slide through the first eyelet of the tissue support portion;and a second extension arm having a second anchor portion and a secondextension member, with at least a length of the second extension armadapted to slide through the second eyelet of the tissue supportportion.
 2. The sling system of claim 1, wherein at least a portion ofthe first extension arm is constructed of a mesh material.
 3. The slingsystem of claim 1, wherein at least a portion of the second extensionarm is constructed of a mesh material.
 4. The sling system of claim 1,wherein the first extension member includes an extension rod.
 5. Thesling system of claim 4, wherein the extension rod is a polymerextension rod.
 6. The sling system of claim 1, wherein the secondextension member includes an extension rod.
 7. The sling system of claim6, wherein the extension rod is a polymer extension rod.
 8. The slingsystem of claim 1, further including a grommet adapted to engage atleast one of the first and second eyelets to facilitate attachment ofthe first extension arm or the second extension arm.
 9. The sling systemof claim 1, further including one or more alignment indicia providedalong a portion of the tissue support portion.
 10. The sling system ofclaim 9, wherein the one or more indicia includes three indicia adaptedto guide placement of the elongate sling relative to tissue targeted forsupport.
 11. The sling system of claim 1, wherein the anchor portion ofat least one of the first and second extension arms is adapted to engagewith obturator tissue.
 12. The sling system of claim 1, wherein theanchor portion of at least one of the first and second extension arms isadapted to engage with rectus fascia.
 13. The sling system of claim 1,wherein the tissue support portion spans under and provides support tothe urethra.
 14. An elongate implantable incontinence sling system,comprising: a tissue support portion having a first eyelet and a secondeyelet; a first extension arm having a first anchor portion, a firstmesh portion, and a first extension member, with at least a length ofthe first mesh portion adapted to slide through the first eyelet of thetissue support portion; and a second extension arm having a secondanchor portion, a first mesh portion, and a second extension member,with at least a length of the second mesh portion adapted to slidethrough the second eyelet of the tissue support portion, such that thetissue support portion spans under and provides support to the urethra.15. The sling system of claim 14, wherein at least a portion of thefirst extension arm is constructed of a mesh material.
 16. The slingsystem of claim 14, wherein at least a portion of the second extensionarm is constructed of a mesh material.
 17. The sling system of claim 14,wherein at least one of the first extension member and the secondextension member includes an extension rod.
 18. The sling system ofclaim 14, wherein the extension rod is a polymer extension rod.
 19. Thesling system of claim 14, further including a grommet adapted to engageat least one of the first and second eyelets to facilitate attachment ofthe first extension arm or the second extension arm.
 20. The slingsystem of claim 14, further including one or more alignment indiciaprovided along a portion of the tissue support portion.